IMvigor011: Positive Surveillance Data Demonstrate Benefits of Signatera

Surveillance data from Natera’s phase 3, randomized IMvigor011 trial, which were presented at the European Association of Urology (EAU) Congress 2024, revealed that patients with muscle invasive bladder cancer (MIBC) may benefit from Signatera, a personalized and tumor-informed molecular residual disease (MRD) test.

The study was led by Thomas Powles, MBBS, MRCP, MD.

Using circulating tumor DNA, Signatera quantifies cancer and the time of any recurrence events to assist in identifying treatment options.

The IMvigor011 trial, sponsored by Genentech, serially tested patients with Signatera for up to 12 months following cystectomy. Researchers randomized those who were Signatera MRD-positive at any time throughout the 12-month surveillance period to anti-PDL1 atezolizumab versus placebo. At the close of the surveillance period, those who remained Signatera-negative continued to receive radiographic imaging.

The study found that patients who were Signatera-positive following radical cystectomy benefitted from treatment with the adjuvant immunotherapy atezolizumab. Signatera-negative patients did not show increased benefits from adjuvant immunotherapy.

The surveillance data presented at the EAU Congress detailed the clinical outcomes of 171 patients with high-risk MIBC who participated in Imvigor011 and stayed MRD-negative throughout the surveillance window.

Investigators found that at 12 months, the overall survival rate was 100%, while at 18 months, the rate was 98%. The disease-free survival rate was 92% at 12 months and 88% at 18 months.

Dr. Powles and colleagues concluded that patients with high-risk MIBC who remained MRD-negative following serial testing with Signatera may not require adjuvant treatment.

“IMvigor011 is an important randomized study that is designed to address a critical unmet need for the more than 35,000 patients a year diagnosed with muscle invasive bladder cancer,” said John Simmons, global vice president, BioPharma, at Natera. “We believe the results of this trial will further demonstrate how Signatera can help personalize treatment decisions and improve outcomes for bladder cancer patients.”